The health regulator sought certain additional data to satisfy requirements pertaining to chemistry, manufacturing, and controls before the treatment, called pz-cel, can be approved, in its so-called "complete response letter". The drug developer is seeking approval for the treatment in patients with recessive dystrophic epidermolysis bullosa, where the skin becomes fragile and blisters can appear through rubbing or exposure to heat. FDA in its response letter indicated that the proposed timing of the data submission would not allow sufficient time to complete its review by May 25, the set deadline to decide on the application.
Victor Hugo Quiroz, 28, was diagnosed with Dystrophic Epidermolysis Bullosa (EB) at birth, a genetic condition that has left him with extremely fragile skin and webbed hands and feet.
Reporting responses in patients with RDEB-associated SCC, a devastating disease with a significant unmet needNEWTOWN, Pa., Oct. 12, 2023 (GLOBE NEWSWIRE) (GLOBE NEWSWIRE) Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that a late-breaking abstract studying rigosertib in patients with recessive dystrophic epidermolysis bullosa (R